The US Food and Drug Administration (FDA) has warned three firms, RoTech Healthcare Inc, CCS Medical, and Reliant Pharmacy Services, to stop manufacturing and distributing thousands of doses of compounded, unapproved inhalation drugs nation-wide. Responsible officials at firms that do not properly address violations identified in FDA warning letters risk further enforcement, including injunctions that prevent further violations and seizure of their products that violate the law.

The three firms warned by FDA say that they produce inhalation drugs as part of the practice of pharmacy compounding. Traditional pharmacy compounding typically involves pharmacies preparing drugs that are not commercially available, such as a unique medicine for a patient who is allergic to an ingredient in a FDA-approved drug. This kind of compounding follows a physician’s decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs. FDA normally permits traditional pharmacy compounding and the agency’s action is not targeting this practice.

Numerous FDA-approved inhalation drugs for the treatment of respiratory disorders such as asthma, emphysema, bronchitis, and cystic fibrosis are available. Compounded inhalation drugs can be distributed to patients in multiple states, and patients and their doctors might not know that they are receiving compounded products. The FDA urges consumers using inhalation drugs to discuss their medications with their physicians and verify with their pharmacists that the medications they received are what their physicians ordered.

“Compounded inhalation drugs are not reviewed by the FDA for safety and effectiveness, often are not produced according to good drug manufacturing practice, and typically are not sterile. This may expose patients to unnecessary risk,” said Steven Galson, MD, MPH, director of FDA’s Center for Drug Evaluation and Research. “To avoid these risks, we encourage patients to use FDA-approved drugs whenever possible.”